Food and Drug Administration: The Major Items to Watch

Healthcare & Life Sciences Team members Jordan Brossi, Michael Werner, Sara Klock, Rachel Gartner and Parker Reynolds wrote an article for The Journal of Federal Agency Action on the U.S. Food and Drug Administration's (FDA) direction under Commissioner Martin Makary during President Donald Trump's second term. They discuss major developments across the agency, including the approaching renewal of user fee programs, rollout of the Over-the-Counter Monograph Drug User Fee Program (OMUFA) and initiatives tied to the U.S. Department of Health and Human Services' (HHS) Make America Healthy Again agenda. They also explore the legal and policy questions surrounding the Commissioner's National Priority Voucher (CNPV) program, changes aimed at reducing animal testing and widening use of real-world evidence and artificial intelligence in clinical trials, as well as expected next steps on cannabis regulation, cell and gene therapies and domestic manufacturing. The authors show how these developments could affect regulated industries as the FDA, Congress and other stakeholders continue to shape the FDA's priorities.

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